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New hope for transplant patients: drug targets stubborn immune attack

NCT ID NCT06343792

Disease control Sponsor: ReAlta Life Sciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called RLS-0071 in 66 hospitalized patients who have severe graft-versus-host disease (GVHD) after a stem cell transplant and did not improve with steroids. The drug is given for 7 to 14 days to see if it is safe and helps control the immune reaction. The goal is to find the right dose and measure how well patients respond.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RLS-0071
What this could lead to
If successful, this could offer a new treatment option for patients with severe graft-versus-host disease that does not respond to steroids.
What could go wrong
This is an early Phase 2 trial with only 66 participants, so results may not apply broadly. The drug may cause side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female adults or adolescents (\>12 years old). * Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT * Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation. * No plans to add additional GvHD treatment medications or to add, dose-adjust, or discontinue GvHD prophylactic medications during the 7-days of RLS-0071 treatment. * Neutrophil recovery following the stem-cell transplantation, defined as blood neutrophil count \>500/mL for at least 3 consecutive measurements and not supported by growth factor supplementation * Weight ≥40 kg and ≤ 140 kg at screening. Exclusion Criteria: * Has received more than 1 allo-HSCT * Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD * Previous failure of ruxolitinib treatment * Uncontrolled GI infection * Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD * Chronic GvHD * Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed. * Unresolved toxicity or complications (other than aGvHD) due to the allo-HSCT * Any corticosteroid therapy for indications other than aGvHD at doses of methylprednisolone or equivalent \>1 mg/kg per day within 7 days of enrollment. * Severe organ dysfunction unrelated to underlying aGvHD * Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG) * Significant liver disease that is unrelated to GvHD * Severe kidney disease * Currently breast feeding. * Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP. * Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or human immunodeficiency virus (HIV)-1 or HIV-2. * Active sepsis

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Steroid refractory GVHD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Site 1068

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

  • Site 1091

    ACTIVE_NOT_RECRUITING

    Duarte, California, 91010, United States

  • Site 1100

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Site 1318

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30041, United States

  • Site 1343

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90095, United States

  • Site 1382

    ACTIVE_NOT_RECRUITING

    Columbus, Ohio, 43210, United States

  • Site 3101

    RECRUITING

    Seville, SE, 41013, Spain

  • Site 3101

    RECRUITING

    Seville, Spain

  • Site 3227

    RECRUITING

    Salamanca, Spain

  • Site 3242

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Site 3360

    RECRUITING

    Madrid, Spain